A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer
Study Details
Study Description
Brief Summary
Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities. Patients will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive identical treatment regimens.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: A Ovarian Cancer Patients |
Drug: MKC-1
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
|
Experimental: B Endometrial Cancer Patients |
Drug: MKC-1
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
|
Outcome Measures
Primary Outcome Measures
- Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125 [Every 4 to 8 weeks]
Secondary Outcome Measures
- Time to progression [Time of progression]
- Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests. [As reported]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provide written informed consent (and HIPAA authorization for release of protected health information, as applicable) prior to any study related assessments.
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Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis, fallopian tube cancers, or endometrial cancer.
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Age > 18 years at the time of consent.
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Arm A: Ovarian Cancer Patients:
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Must have failed at least one prior platinum based and one taxane based chemotherapeutic regimen. [Platinum failure is defined as platinum-refractory (progression while receiving a platinum-containing regimen) or platinum-resistant (disease progression within 6 months from completion of platinum containing regimen)].
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Have measurable disease according to RECIST or CA 125 criteria according to GCIG (CA-125 value of > 2 xULN).
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Have no more than 3 prior regimens for their disease.
Arm B: Endometrial Cancer Patients:
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Have no more than 3 prior regimens for their disease
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Have measurable disease according to RECIST.
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ECOG performance status of 0, 1, or 2.
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The following laboratory results, within 10 days of MKC-1 administration:
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Hemoglobin greater than or equal to 90 g/L (9 g/dL)
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Absolute neutrophil count greater than or equal to 1.5 x 109/L
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Platelet count greater than or equal to 100 x 109/L
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Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)
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AST less than or equal to 2.5 x ULN
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Serum Albumin greater than or equal to 30 g/L (3.0 g/dL)
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Total bilirubin less than or equal to ULN
Exclusion Criteria:
- Administration of cancer specific therapy within the following periods prior to study drug initiation:
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chemotherapy less than 3 weeks prior;
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hormonal therapy less than one week prior;
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radiation therapy less than 2 weeks prior.
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Requirement for paracentesis > 2 liters/week.
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Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical method of contraception. Female patient with childbearing potential must have a negative pregnancy test within 10 days before the first MKC-1 administration.
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Known CNS metastases unless treated, clinically stable, and not requiring steroids.
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Clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
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Uncontrolled hypercalcemia (serum calcium-corrected > 3 mmol/L [12 mg/dL]).
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Serious cardiac condition (Class III/IV congestive heart failure according to New York Heart Association classification); documented acute myocardial infarction within the previous 6 months.
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Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. These include: infection requiring parenteral or oral anti-infective treatment, any altered mental status, or any psychiatric condition that would interfere with the understanding of the informed consent.
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Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix.
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Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
2 | Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | Canada | K7L 5P9 |
3 | London Health Sciences Centre | London | Ontario | Canada | N6A 4L6 |
4 | Credit Valley Hospital | Mississauga | Ontario | Canada | L5M 2N1 |
5 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
6 | Hopital Notre-Dame du CHUM | Montreal | Quebec | Canada | H2L 4M1 |
Sponsors and Collaborators
- CASI Pharmaceuticals, Inc.
Investigators
- Principal Investigator: Amit Oza, MD, Princess Margaret Hospital, Canada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MKC-103